OraStretch® Bitepad Pack – Standard

Basic Information

• Brand Name: OraStretch® Bitepad Pack – Standard
• Primary DI: 00850056079051
• Version / Model: CR1050
• Company Name: Cranio Mandibular Rehab, Inc.
• Labeler DUNS: 048276773
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-01
• Public Version: 1
• Public Version Date: 2024-04-09
• Public Version Status: New
• Public Device Record Key: b35c3131-941e-4ba0-ac57-a71d681617d5

Device Description

The OraStretch Bitepads are self-adhesive pads used with the OraStretch press device to cushion the user's teeth. This pack includes 4 standard sized bitepads.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ION	Exerciser, Non-Measuring	Physical Medicine	890.5370	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17802	Mastication muscle exerciser	An intraoral mechanical exercise apparatus intended primarily to strengthen and rehabilitate the jaw muscles of mastication of a patient who has pain in, or disorders of, the temporomandibular joint (TMJ), typically through repetitive biting against resistive forces provided by the device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850056079051	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	60	Millimeter